Paracetamol 250mg Suppositories

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Paracetamol

متاح من:

Phoenix Labs

ATC رمز:

N02BE; N02BE01

INN (الاسم الدولي):

Paracetamol

جرعة:

250 milligram(s)

الشكل الصيدلاني:

Suppository

نوع الوصفة الطبية :

Product not subject to medical prescription

المجال العلاجي:

Anilides; paracetamol

الوضع إذن:

Marketed

تاريخ الترخيص:

2010-12-21

نشرة المعلومات

PHOENIX LABS
Information for the user
FOR RECTAL ADMINISTRATION ONLY
PARACETAMOL 250MG SUPPOSITORIES
PARACETAMOL 500MG SUPPOSITORIES
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU GIVE THIS MEDICINE TO
YOUR CHILD BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU AND YOUR CHILD. This medicine is
available without prescription.
However, you still need to use it carefully to get the best results
from it.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If your child gets any side effects
talk to your child’s doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section
4.YOU MUST TALK TO A DOCTOR
IF YOUR CHILD DOES NOT FEEL BETTER OR IF YOUR CHILD FEELS WORSE.
What is in this leaflet:
1 .
What Paracetamol Suppositories are and what are they used for
2.
What you need to know before you give Paracetamol Suppositories to
your child
3.
How to use Paracetamol Suppositories
4.
Possible side effects
5.
How to store Paracetamol Suppositories
6.
Contents of the pack and other information
1.
WHAT PARACETAMOL SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR
Paracetamol Suppositories contain a medicine called paracetamol.
Paracetamol is one of a group of
medi-cines called pain-killers (analgesics). A suppository is a small,
torpedo-shaped medicine which
is inserted into the back passage (rectum). Paracetamol Suppositories
are used to treat pain and
high temperature (fever) in children from the age of 6 years. They are
used by children who find it
difficult to take paracetamol as tablets or syrup.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE PARACETAMOL SUPPOSITORIES TO
YOUR CHILD
DO NOT GIVE YOUR CHILD THESE SUPPOSITORIES IF:
•
They are allergic to paracetamol or the other main ingredient which is
called "hard fat".
WARNINGS AND PRECAUTIONS
Talk to your child’s doctor or pharmacist before using these
suppositories:
•
If your child has liver or kidney problems
OTHER MEDICINES AND PARACETAMOL SUPPOSITORIES
Please tell y

خصائص المنتج

Health Products Regulatory Authority
24 May 2022
CRN00CY1Y
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 250mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 250mg Paracetamol
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suppository
White, torpedo shaped, suppository
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of mild to moderate pain and fever in children.
Paracetamol 250 mg Suppositories are indicated in children from the
age of 6 years.
Paracetamol suppositories may be especially useful in patients unable
to take oral forms of paracetamol e.g. Post-operative
patients or patients with nausea and/or vomiting.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population_
The dosage should be based on the child's age and weight. Ages and
weight ranges presented below are provided as an
accompanying guide only.
Children aged 6 – 9 years (20 - 30kg): 1 suppository
Children aged 10 – 12 years (30 - 40kg): 1 - 2 suppositories
Method of administration
For rectal use only.
These doses may be repeated up to a maximum of 4 times in 24 hours.
The dose should not be repeated more frequently than
every 4 hours. The recommended dose should not be exceeded. The
product should not be used for more than 3 days, except
on the advice of a doctor. Higher doses do not produce any increase in
analgesic effect. Only whole suppositories should be
administered – do not break the suppository before administration.
_ _
_Hepatic / renal dysfunction_
Caution should be exercised when administering the product to patients
with severe hepatic or renal impairment.
4.3 CONTRAINDICATIONS
Patients who are hypersensitive to paracetamol or any of the other
constituents.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Paracetamol suppositories should not be combined with other analgesic
medications that contain paracetamol. Paracetamol
suppositories should be administered with care to patients with
impaired